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Clinical Trials and Expanded Access

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Around the world, researchers are working extremely hard to develop new treatments and interventions for COVID-19 with new clinical trials opening nearly every day. This directory provides you with information, including enrollment detail, about these trials. In some cases, researchers are able to offer expanded access (sometimes called compassionate use) to an investigational drug when a patient cannot participate in a clinical trial.

The information provided here is drawn from ClinicalTrials.gov. If you do not find a satisfactory expanded access program here, please search in our COVID Company Directory. Some companies consider expanded access requests for single patients, even if they do not show an active expanded access listing in this database. Please contact the company directly to explore the possibility of expanded access.

Emergency INDs

To learn how to apply for expanded access, please visit our Guides designed to walk healthcare providers, patients and/or caregivers through the process of applying for expanded access. Please note that given the situation with COVID-19 and the need to move as fast as possible, many physicians are requesting expanded access for emergency use. In these cases, FDA will authorize treatment by telephone and treatment can start immediately. For more details, consult FDA guidance. Emergency IND is the common route that patients are receiving convalescent plasma.

Search Tips

To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.

Displaying 10 of 14

The Cleveland Clinic

Coronavirus 2019 (COVID-19)- Using Ascorbic Acid and Zinc Supplementation

Conditions: COVID, Corona Virus Infection

The purpose of this study is to examine the impact of ascorbic acid (vitamin c) and zinc gluconate in reducing duration of symptoms in patients diagnosed with coronavirus disease 2019 (COVID-19). Patients above the age of 18 who present to the Cleveland Clinic outpatient testing and receive a positive test for COVID-19 will be invited to participate.

Emory University, Georgia Tech Research Foundation, Georgia Clinical & Translational Science Alliance

Trans Thoracic Manipulation of Ventilation/Perfusion: the V/Q Vest for COVID-19

Conditions: Acute Respiratory Distress Syndrome, COVID-19

The objective of this research is optimizing oxygenation in patients in the setting of acute hypoxic respiratory failure in relation to corona virus disease 2019 (COVID-19) through non-invasive manipulation as a complementary therapy to traditional advanced mechanical ventilator support, or as a marker of responsivity to supportive therapies. The intent is to determine if it is possible to physically improve the ability of the lungs to take up oxygen by applying external pressure to the chest. It is hypothesized that the use of the vest for this patient population will alter the blood flow through the lungs and thereby improve oxygen levels in the body. Participants will wear the ventilation/perfusion (V/Q) vest for 2 hours and study activities will last up to 4 hours.

University of Arizona

Effects of Mobile App in House Staff Health and Well-being During COVID-19 Pandemic

Conditions: Perceived Stress, Anxiety, Sleep Disturbance, Burnout, PTSD

Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective evaluation of perceived stress, anxiety, burnout and sleep disturbance in the house staff at Banner University Medical Center Phoenix, with the use of the mobile meditation app, "Calm." The investigatros additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and physician satisfaction with use of the app.

Providence Health & Services, Center for Outcomes Research and Education, Providence Cancer Center, Earle A. Chiles Research Institute

Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care

Conditions: COVID-19, Corona Virus Infection, SARS-CoV-2, 2019-nCoV, 2019 Novel Coronavirus

This study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19

Bursa City Hospital

Do Vitamin D Levels Really Correlated With Disease Severity in COVID-19 Patients?

Conditions: COVID

Blood vitamin D levels may be associated with COVID-19 disease severity, we aimed to find out whether blood 25-hydroxy vitamin D (25(OH)D) levels were correlated with COVID-19 disease severity or noy.

University of Wisconsin, Madison, National Institutes of Health (NIH), AIDS Vaccine Research Lab

Rapid, Onsite COVID-19 Detection

Conditions: COVID-19, SARS-COV2

The purpose of this research study is to evaluate and improve a rapid COVID-19 test. The test is designed to identify people who are most contagious and likely to spread the virus to others. This test will be performed at various locations in the Madison area using a mobile laboratory or standard lab space for processing. Saliva samples can be collected and processed at these locations or participants can self-collect at home and drop their samples off at designated locations for same day processing. Results of potential findings of clinical significance will be communicated to the participants by a physician with appropriate expertise on the study team. Individuals with a potential finding of clinical significance will be encouraged to self-isolate and obtain a diagnostic test at their earliest convenience. No results will be given if the test is negative. If the participant consents, advanced molecular testing such as PCR or viral sequencing can be done and results can be shared via online databases, presentations and publications along with the date, site and county of collection to help facilitate tracking the spread of the virus.

University of Colorado, Denver, Children's Hospital Colorado

Compensatory Reserve Index (CRI) for Management of COVID-19

Conditions: COVID

The FDA has approved the CipherOx CRI T1 Tablet for use in subjects aged 19-36, and that this study aims to evaluate the device in subjects aged outside of this range and is being used off label. The FDA determined the Cipher OX CRI T1 Tablet to be a class II device in 2016, and additional research has been done since the FDA determination to further support the use of the device outside of its current labeling.

Johns Hopkins University

Tele-Wellness Supported App for Family Child Care Home Providers and Families to Promote Health, Family Engagement, and School Readiness Amid COVID-19

Conditions: Stress, Psychological, Child Behavior, Social Competence

The investigators aim to deliver a tele-wellness supported app to Baltimore City's Family Child Care Home (FCCH) providers who are caring for children of Essential Personnel. Once a pre-survey is conducted, login information will be assigned to 30 Family Child Care Home providers and parents the FCCH serve. Providers and Parents will receive self-care and parenting/parent engagement support through the app and through a tele-wellness service, Ask a Nurse, provided by community health nurses at the Johns Hopkins School of Nursing. Children will have access to gamified learning materials in early literacy, math, social-emotional learning, and nutrition.

physIQ, Inc., National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Cancer Institute (NCI), University of Illinois at Chicago

Detection of COVID-19 Decompensation

Conditions: COVID19

In this study we will be monitoring for patient events (emergency department admission, hospital admission, admission to an observation unit, or death) and evaluating the feasibility and utility of using pinpointIQ in the management of patients with COVID-19. Vital sign (physiology data) is collected to build a Covid Decompensation Index and contribute data to a Covid Digital Hub supported by the National Institutes of Health.

Mayo Clinic

Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19

Conditions: Healthy, Health Care Worker Patient Transmission, Aging

The purpose of this research study is to look at high dose zinc versus multivitamin micronutrient supplementation to support immune health in the setting of the COVID-19 pandemic.

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Status

  • Recruiting (214)
  • Not yet recruiting (93)
  • Active, not recruiting (22)
  • (-) Enrolling by invitation (14)
  • Completed (3)
  • Expanded Access (1)

Intervention Type

  • Other (48)
  • Drug (28)
  • Behavioral (21)
  • Diagnostic Test (21)
  • Biological (15)
  • (-) Device (10)
  • Procedure (5)
  • (-) Dietary Supplement (4)
  • Combination Product (3)
  • Genetic (1)
  • Radiation (1)

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© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA